Halyard 13721Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651137217), received between Oct 27, 2017 and Oct 25, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K063530); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2019Break; Break

  IT WAS REPORTED THAT WHEN THE PATIENT WAS TO HAVE THE CATHETERS REMOVED, ONE CAME OUT FINE WHILE THE OTHER ONE GAVE RESISTANCE, STRETCHED, AND BROKE. THE SURGEON WAS UNABLE TO VISUALIZE THE FRAGMENT IN AN X-RAY BUT ESTIMATES THAT THE PIECE LEFT IN THE PATIENT IS ABOUT AN INCH LONG. THE PATIENT WILL RETURN THE FOLLOWING WEEK TO HAVE THE PIECE REMOVED. PER ADDITIONAL INFORMATION RECEIVED ON 8 OCT 2019, THE PATIENT HAS CEREBRAL PALSY AND WAS UNABLE TO KEEP STILL DURING THE CATHETER REMOVAL PROCESS. THE SURGEON FEELS THAT THE CATHETER MAY HAVE GOTTEN CAUGHT ON AN INTERNAL SCREW.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9240860 ↗
• InjuryOct 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE: HEMORRHOIDECTOMY. IT WAS REPORTED THAT A PATIENT DEVELOPED AN ABSCESS WHILE USING THE ON-Q. THE PATIENT DEVELOPED AN ABSCESS POST HEMORRHOIDECTOMY AT THE INSERTION SITE OF THE ON-Q. THE HEMORRHOIDECTOMY WOUND WAS CLEAN AND NOT AFFECTED AS THE PUS POCKET REMAINED LATERAL WITH NORMAL SKIN BETWEEN THE TWO AREAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abscess

  MAUDE report 6983268 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063530. One submission often covers many models, so check the product and lot details in each record.

• Z-2860-2011 · Apr 15, 2011 · Terminated
  I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for p
• Z-2133-2008 · Feb 14, 2008 · Terminated
  On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narc
• Z-1869-2008 · Feb 12, 2008 · Terminated
  ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anest